DPOAE20 , ECLIPSE

K060539 · Interacoustics A/S, Assens · EWO · May 30, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K060539
• Device Name: DPOAE20 , ECLIPSE
• Applicant: Interacoustics A/S, Assens
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli. The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation. This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.

Device Story

The DPOAE20 system is an audiometric device used by ENT doctors, neurologists, and audiologists to assess cochlear outer hair cell function. It utilizes an ear probe placed in the patient's ear canal to deliver Distortion Product Otoacoustic Emission (DPOAE) tone stimuli. The device records the resulting OAE response, processes the signal via the Eclipse hardware and DPOAE20 software, and displays the results on a computer screen. Clinicians use these outputs to evaluate auditory function and identify potential ear disorders. The system provides objective data to support clinical decision-making regarding hearing health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

The device is an audiometer (Product Code EWO) consisting of an ear probe for stimulus delivery and signal acquisition, connected to the Eclipse system hardware and software for processing and display. It operates by generating DPOAE tone stimuli and measuring cochlear responses.

Indications for Use

Indicated for audiologic evaluation and documentation of ear disorders in patients of all ages and genders.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2006

Interacoustics A/S, Assens c/o Mr. Daniel Eggan Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344

Re: K060539

Trade/Device Name: DPOAE20, Eclipse Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: February 6, 2006 Received: March 24, 2006

Dear Mr. Eggan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 – Mr. Daniel Eggan

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo tetel notification. The FDA finding of substantial equivalence of your device to a legally promation houring results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you a stato office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notifieation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottorers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours;

M.B. Eckhaus, M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DPOAE20 - Eclipse System 510k Notification

Revision A

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## Indications for Use

510(k) Number (if known):

Device Name: DPOAE20 Indications For Use:

The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.

The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.

This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.

The patient group includes all ages and sexes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K660539

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Author Ejvind Christensen

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